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Clinical Trial
. 2021 May;124(10):1647-1652.
doi: 10.1038/s41416-021-01313-0. Epub 2021 Mar 24.

The added value of H2 antagonists in premedication regimens during paclitaxel treatment

Juul M Cox #  1 , Leni van Doorn #  2 , Ruben Malmberg  2   3 , Esther Oomen-de Hoop  2 , Tessa M Bosch  1 , Patricia M L A van den Bemt  4 , Ingrid A Boere  2 , Agnes Jager  2 , Ron H J Mathijssen  2 , Roelof W F van Leeuwen  5   6
Affiliations
Clinical Trial

The added value of H2 antagonists in premedication regimens during paclitaxel treatment

Juul M Cox et al. Br J Cancer. 2021 May.

Abstract

Background: Ranitidine, a histamine 2 blocker, is the standard of care to prevent hypersensitivity reactions (HSRs) caused by paclitaxel infusion. However, the added value of ranitidine in this premedication regimen is controversial. Therefore, we compared the incidence of HSRs during paclitaxel treatment between a standard regimen including ranitidine and a regimen without ranitidine.

Methods: This prospective, pre-post interventional, non-inferiority study compared the standard premedication regimen (N = 183) with dexamethasone, clemastine and ranitidine with a premedication regimen without ranitidine (N = 183). The primary outcome was the incidence of HSR grade ≥3. Non-inferiority was determined by checking whether the upper bound of the two-sided 90% confidence interval (CI) for the difference in HSR rates excluded the +6% non-inferiority margin.

Results: In both the pre-intervention (with ranitidine) and post-intervention (without ranitidine) group 183 patients were included. The incidence of HSR grade ≥3 was 4.4% (N = 8) in the pre-intervention group and 1.6% (N = 3) in the post-intervention group: difference -2.7% (90% CI: -6.2 to 0.1).

Conclusions: As the upper boundary of the 90% CI does not exceed the predefined non-inferiority margin of +6%, it can be concluded that a premedication regimen without ranitidine is non-inferior to a premedication regimen with ranitidine.

Clinical trial registration: www.trialregister.nl ; NL8173.

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Conflict of interest statement

R.H.J.M. reports research grants from Astellas, Bayer, Boehringer-Ingelheim, Cristal Therapeutics, Pfizer, Prostakan, Roche and Pamgene. Personal fees from Novartis and Servier; all outside the submitted work. R.W.F.v.L. reports research grants from Astellas, Bayer, Boehringer-Ingelheim, Bristol Myers Squibb, Servier and Roche. Personal fees from Roche, Pfizer and Sanofi; all outside the submitted work. All other authors declare no potential competing interests.

Figures

Fig. 1
Fig. 1. Distribution of patients.
Patients who experienced a hypersensitivity reaction (HSR) in the pre-intervention group with ranitidine and the post-intervention group without ranitidine. Data are presented as N (%).
See this image and copyright information in PMC

Comment in

References

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